PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study (PICRcarriage)

Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims:

1. To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies.
2. To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus and S. pneumoniae in different regions of the PICR.

Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.

Study Overview

• Status: Unknown
• Conditions: Streptococcus Pneumoniae
• Intervention / Treatment: Biological: PCV

Detailed Description

Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.

PICR districts: 1. Palestinian Authority (PA) - particularly: Bethlehem, Ramallah and Nabulus. 2. East Jerusalem (EJ) 3. Central Israel (IL) - particularly: Rishon Lezion, Bat Yam, Holon 4. Gaza strip (GZ) - 12 regions including cities/villages in central/northern Gaza.

Study population:

Child (age 0-5y) & Parent who attend clinics (for any reason).

Exclusion criteria:

Parent does not agree to sign informed consent Child or sibling (brother/sister) have already participated.

Both healthy and ill children are screened. No specific exclusion other than the above.

Only one child per family (younger child, if more than one available) and one parent (mother, if both are available).

Sample size per year:

IL: Central Israel (Hashfela District): 400 pairs of child+parent/surveillance EJ: East Jerusalem: 400 pairs of child+parent/surveillance PA: West Bank cities (Ramallah, Bethlehem & Nabulus): 600 pairs of child+parent/surveillance GZ: Gaza strip: 300 pairs of child+parent/surveillance

Study Period:

May-August annually 2009 - 2011 - (Part a). May-August biannually 2014-2016-2018-2020 Current study (Part b).

Screening Procedure:

1. Parent signs informed consent
2. Put Barcode stickers on informed consent, questionnaire, swabs and daily list
3. Fill questionnaire with parent.
4. Fill physician questionnaire
5. Nasal & nasopharyngeal swab of child and parent.
6. Fill daily working table.
7. Write the number of refusals (parents who refused) on daily table.
8. Fill questionnaire FULLY (unmarked questions will not be analyzed) - put x on each question - whether YES or NO.

Swabbing:

1. First swab the child and then follow with the parent.
2. First perform nasal swab (for S. aureus) using cotton-tip swab placed into Amies transport Media (Blue) and follow with nasopharyngeal swab ( for S. pneumoniae) using rayon-tipped aluminum shaft swab placed in Amies transport Media (Orange).
3. Slightly wet the nasal swab with sterile saline. Swab both anterior nares.
4. Nasopharyngeal swab of only through one nostril - gently, quickly and deep to nasopharynx - until you touch the nasopharyngeal wall.

Swab transfer to lab:

If swabs are stored overnight before transfer - keep in 40C (fridge). Within 24h swabs must reach the central laboratory (Dr. Regev-Yochay's Lab at Sheba Medical Center).

• Study Type: Observational
• Enrollment (Anticipated): 12800

Contacts and Locations

• Study Contact: Name: Gili Regev-Yochay, MD; Phone Number: 0526666197; Email: gili.regev.y@gmail.com
• Study Contact Backup: Name: Ziad Abdeen, PhD; Email: zabdeen13@gmail.com

Study Locations

• Israel
  • Ramat-Gan, Israel, 5265601
    • Recruiting
    • Sheba Medical Center
    • Contact: Gili Regev-Yochay; Phone Number: 0526666197

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Child (age 0-5y) & Parent who attend pediatric clinics (for any reason), in the participating clinics during the surveillance periods.

Description

Inclusion Criteria:

• Any child younger than 5 years, visiting the participating clinics during the surveillance period

Exclusion Criteria:

• Older than 5 years
• Previously participated in the study.
• Sibling has participated in the study.
• Parent does not agree to sign informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Israel PCV13; Children and their parents living in central Israel and visiting primary pediatric clinics of Hashfela District, Macabbi Healthcare Services HMO, for any reason during the surveillance period each year.	Biological: PCV; PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011; Other Names: PCV10; PCV13; PCV7
East Jerusalem PCV13; Children and their parents living in East Jerusalem and visiting primary pediatric clinics of Jerusalem District, Macabbi Healthcare Services HMO, for any reason during the surveillance period each year.	Biological: PCV; PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011; Other Names: PCV10; PCV13; PCV7
Palestine PCV7 PCV10; Children and their parents living in major cities of the Palestinian Authority and visiting private primary pediatric clinics, for any reason during the surveillance period each year.	Biological: PCV; PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011; Other Names: PCV10; PCV13; PCV7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S. pneumoniae carriage	S. pneumoniae carriage of children and parents by the different groups	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carriage of Vaccine-type S. pneumoniae	Carriage of Vaccine-type S. pneumoniae in children and parents by the different groups	1 Day
Carriage of antibiotic resistant S. pneumonia	Carriage of antibiotic resistant S. pneumonia in children and parents by the different groups	1 Day
Carriage of piliated S. pneumonia	Carriage of piliated S. pneumonia in children and parents by the different groups	1 Day
Carriage of MRSA	Carriage of MRSA in children and parents by the different groups	1 Day
S. aureus carriage	S. aureus carriage of children and parents by the different groups	1 Day

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: United States Agency for International Development (USAID); Maccabi Healthcare Services, Israel; Palestinian-Israeli Collaborative Research (PICR); The Israeli National Institute for Health Policy Research
• Investigators: Study Chair: Dror Harats, Prof., IRB Committee Sheba Medical Center Israel

Publications and helpful links

General Publications

• Daana M, Rahav G, Hamdan A, Thalji A, Jaar F, Abdeen Z, Jaber H, Goral A, Huppert A, Raz M, Regev-Yochay G; PICR study group. Measuring the effects of pneumococcal conjugate vaccine (PCV7) on Streptococcus pneumoniae carriage and antibiotic resistance: the Palestinian-Israeli Collaborative Research (PICR). Vaccine. 2015 Feb 18;33(8):1021-6. doi: 10.1016/j.vaccine.2015.01.003. Epub 2015 Jan 12.
• Southern J, Roizin H, Daana M, Rubin C, Hasleton S, Cohen A, Goral A, Rahav G, Raz M, Regev-Yochay G; PICR group. Varied utilisation of health provision by Arab and Jewish residents in Israel. Int J Equity Health. 2015 Aug 7;14:63. doi: 10.1186/s12939-015-0193-8.
• Regev-Yochay G, Abullaish I, Malley R, Shainberg B, Varon M, Roytman Y, Ziv A, Goral A, Elhamdany A, Rahav G, Raz M; Palestinian-Israeli Collaborative Research Study Group. Streptococcus pneumoniae carriage in the Gaza strip. PLoS One. 2012;7(4):e35061. doi: 10.1371/journal.pone.0035061. Epub 2012 Apr 23.
• Biber A, Abuelaish I, Rahav G, Raz M, Cohen L, Valinsky L, Taran D, Goral A, Elhamdany A, Regev-Yochay G; PICR Study Group. A typical hospital-acquired methicillin-resistant Staphylococcus aureus clone is widespread in the community in the Gaza strip. PLoS One. 2012;7(8):e42864. doi: 10.1371/journal.pone.0042864. Epub 2012 Aug 16.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: PCV effects; S. pneumoniae carriage; S. aureus carriage; Indirect vaccination effects; Palestinian-Israeli Collaborative Research (PICR)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: 8024-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No